Actively Recruiting
A Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled and Open-label Study to Evaluate the Efficacy and Safety of a Single Dose of IPN10200 in the Improvement of Moderate to Severe Glabellar Lines in Adult Participants, and to Evaluate the Long-term Efficacy and Safety of Repeat Doses of IPN10200
Led by Ipsen · Updated on 2026-04-30
1300
Participants Needed
60
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of IPN10200, a treatment for moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows. The study focuses on adult participants and includes both a double-blind phase comparing a single dose of IPN10200 to placebo, and an open-label phase assessing repeat doses over time. The study aims to understand how well IPN10200 works and how safe it is for improving these facial lines. Participants may receive IPN10200 or placebo injections into specific muscles in the glabellar region during the double-blind phase. In the open-label phase, new participants and those rolling over from the double-blind phase may receive IPN10200 for up to four treatment cycles. The study includes a screening period of up to 20 days, a treatment period with multiple visits in the first month followed by monthly visits, and a 24-week follow-up after the last injection to monitor health. Throughout the study, participants will have health assessments including blood tests, physical exams, clinical evaluations, and ECGs. They will also complete questionnaires and keep diaries. Researchers will measure treatment response at specific weeks using scales that evaluate wrinkle severity and participant satisfaction. Safety and long-term effects including antibody development and adverse events will be closely monitored. Each participant may be involved for up to 107 weeks and can withdraw at any time.
CONDITIONS
Brief Title
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is male or female, aged 18 years or older at the time of consent.
- Has moderate or severe glabellar lines at maximum frown, assessed by validated 4-point scales.
- Is dissatisfied or very dissatisfied with their glabellar lines as measured by a satisfaction score.
- Female participants must use contraception according to local regulations.
- Able to give signed informed consent and comply with study requirements.
- Has time and ability to complete the study and follow instructions.
- Does not live in an institution by administrative or court order.
- Is not a sponsor employee, clinical research staff, or immediate family member of such individuals.
You will not qualify if you...
- Active skin infection or problems in the upper face including the glabellar area.
- History of upper facial surgery such as eyelid blepharoplasty or brow lift within the past 5 years.
- History of facial nerve palsy.
- Marked facial asymmetry, ptosis, excessive skin, deep scarring, or thick sebaceous skin.
- Closed-angle glaucoma or predisposition to it (Japan only).
- Medical conditions increasing risk with botulinum toxin exposure (e.g., myasthenia gravis).
- Scars, piercings, or tattoos near the treatment area within 6 months prior to baseline.
- Botox or similar treatments within 9 months before study start.
- Prior treatment with IPN10200 in any study.
- Use of medications affecting neuromuscular transmission within 30 days prior to baseline.
- Use of aminoglycoside antibiotics within 30 days prior to baseline (except topical outside injection area).
- Use of systemic retinoids within 30 days prior and planned use during the study.
- Prior permanent or nonpermanent facial fillers or aesthetic procedures in the treatment area within specified timeframes.
- Planned cosmetic surgery or aesthetic procedures to the upper face during the study.
- Past surgery in the upper facial line area.
- Use of experimental devices or drugs within specified timelines prior to study.
- Known positive for hepatitis B, C, HIV, or diagnosis of AIDS.
- Significant psychiatric disorders affecting participation.
- Inability to reduce glabellar lines as assessed by the investigator.
- Known allergy or hypersensitivity to botulinum toxin or IPN10200 ingredients.
- History of drug abuse.
- Uncontrolled systemic or significant medical conditions harmful for study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks for the double-blind phase; up to 104 weeks including the open-label phase
Participants receive a single injection of IPN10200 or placebo into the muscles between the eyebrows to treat moderate to severe glabellar lines. Repeat doses may be given in subsequent treatment cycles for participants new to treatment.
Multiple post-treatment visits up to week 52 in the double-blind phase; follow-up visits continue up to week 104 in the open-label phase
Trial Site Locations
Total: 60 locations
1
Rivkin Westside Aesthetics
Los Angeles, California, United States, 90025
Not Yet Recruiting
2
Clinical Testing of Beverly Hills
Los Angeles, California, United States, 91436
Actively Recruiting
3
Eye Research Foundation
Newport Beach, California, United States, 92663
Actively Recruiting
4
Steve Yoelin MD Medical Associates Inc
Newport Beach, California, United States, 92663
Actively Recruiting
5
Skin and Beauty Center
Pasadena, California, United States, 91105
Actively Recruiting
6
Dermatology Cosmetic Laser Medical Associates of La Jolla Inc.
San Diego, California, United States, 92121
Not Yet Recruiting
7
Southern California Dermatology, Inc.
Santa Ana, California, United States, 92701
Not Yet Recruiting
8
DMR Research, PLLC
Westport, Connecticut, United States, 06880
Actively Recruiting
9
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, United States, 20037
Not Yet Recruiting
10
Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
11
Weinkle Dermatology
Bradenton, Florida, United States, 34209
Actively Recruiting
12
Skin Research Institute
Coral Gables, Florida, United States, 33146
Not Yet Recruiting
13
Miami Dermatology & Laser Research
Miami, Florida, United States, 33133
Actively Recruiting
14
Kavali Plastic Surgery and Skin Renewal Center
Atlanta, Georgia, United States, 30328
Actively Recruiting
15
DeNova Research
Chicago, Illinois, United States, 60610
Actively Recruiting
16
Chicago Cosmetic and Dermatologic Research
Chicago, Illinois, United States, 60654-5826
Actively Recruiting
17
Advanced Dermatology, A Forefront Dermatology Practice
Lincolnshire, Illinois, United States, 60069
Not Yet Recruiting
18
LASSI - Laser and Skin Surgery Center of Indiana
Indianapolis, Indiana, United States, 46260
Actively Recruiting
19
Coleman Center For Cosmetic Dermatologic Surgery
Metairie, Louisiana, United States, 70006
Not Yet Recruiting
20
DelRicht Research
New Orleans, Louisiana, United States, 70115
Actively Recruiting
21
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, United States, 70130
Actively Recruiting
22
Maryland Laser, Skin, & Vein Institute, LLC (MDLSV)
Hunt Valley, Maryland, United States, 21030
Actively Recruiting
23
Lawrence J. Green, MD. LLC
Rockville, Maryland, United States, 20850
Actively Recruiting
24
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
Actively Recruiting
25
Michigan Center for Research Company
Clarkston, Michigan, United States, 48346
Actively Recruiting
26
Skin Specialists PC dba Schlessinger MD
Omaha, Nebraska, United States, 68144
Actively Recruiting
27
StracSkin
Portsmouth, New Hampshire, United States, 03801
Actively Recruiting
28
Rejuva Center at Williams
Latham, New York, United States, 12110
Actively Recruiting
29
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco, New York, United States, 10549
Actively Recruiting
30
Luxurgery
New York, New York, United States, 10021
Actively Recruiting
31
Dr. Z. Paul Lorenc MD, Office Of
New York, New York, United States, 10028
Actively Recruiting
32
Skin Search Of Rochester, Inc.
Rochester, New York, United States, 14623
Actively Recruiting
33
Rochester Dermatologic Surgery, P.C.
Victor, New York, United States, 14561
Not Yet Recruiting
34
Aesthetic Solutions P.A.
Chapel Hill, North Carolina, United States, 27517
Actively Recruiting
35
Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office
Charlotte, North Carolina, United States, 28207
Actively Recruiting
36
Nash Research Group, LLC
Powell, Ohio, United States, 43065
Actively Recruiting
37
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Actively Recruiting
38
Paddington Testing Company
Philadelphia, Pennsylvania, United States, 19103
Actively Recruiting
39
Brian S. Biesman MD, PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
40
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Actively Recruiting
41
Center for Clinical Studies
Webster, Texas, United States, 77598
Not Yet Recruiting
42
Sas Aimed
Lyon, France, 69006
Not Yet Recruiting
43
Institut Cyrnos
Nice, France, 6000
Not Yet Recruiting
44
Thinkin SAS
Paris, France, 75016
Not Yet Recruiting
45
Rosenpark Research GmbH
Darmstadt, Germany, 64283
Not Yet Recruiting
46
Privatpraxis Dr. Hilton & Partner
Düsseldorf, Germany, 40212
Not Yet Recruiting
47
Universitaet Hamburg - Institut fuer Biochemie und Molekularbiologie
Hamburg, Germany, 20146
Not Yet Recruiting
48
Derma Science GmbH
Hamburg, Germany, 22609
Not Yet Recruiting
49
Noahklinik- Klinik fuer Plastische Chirurgie
Kassel, Germany, 34117
Not Yet Recruiting
50
Dermatologische Gemeinschaftspraxis
Mahlow, Germany, 15831
Not Yet Recruiting
51
Skin Concept - Private Dermatology Practice
München, Germany, 80333
Not Yet Recruiting
52
Haut- und Lasercentrum Potsdam
Potsdam, Germany, 14467
Not Yet Recruiting
53
Akihabara Skin Clinic
Chiyoda-ku, Japan, 101-0021
Actively Recruiting
54
Medical Corporation Chiseikai - Tokyo Center Clinic
Chūōku, Japan, 103-0027
Actively Recruiting
55
Josui Dermatology Clinic
Fukuoka, Japan, 810-0022
Actively Recruiting
56
Clinica BellaForma
Minatoku, Japan, 107-0052
Actively Recruiting
57
Forest Palace Dermatology Clinic
Nerima-ku, Japan, 177-0041
Actively Recruiting
58
Kume Derma Clinic
Sakaishi, Japan, 593-8324
Actively Recruiting
59
Kotoni Tower Dermatology and Plastic Surgery
Sapporo, Japan, 063-0812
Actively Recruiting
60
Yoshikawa Skin Clinic
Takatsuki-shi, Japan, 569-0824
Actively Recruiting
Research Team
I
Ipsen Recruitment Enquiries
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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